Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT00059761
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer by one of two methods:
* Fine needle aspiration biopsy
* Two positive sputa
* Must have limited disease as defined by all of the following:
* Stage I-IIIB
* Confined to 1 hemithorax
* No T4 tumor based on malignant pleural or pericardial effusion
* Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed
* No N3 disease based on contralateral hilar or contralateral supraclavicular involvement
* Measurable or evaluable disease
* Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise
* No complete tumor resection
* No pericardial effusion (regardless of cytology)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 120,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* No known Gilbert's disease
Renal
* Creatinine no greater than 1.5 mg/dL
Cardiovascular
* No myocardial infarction within the past 6 months
* No symptomatic heart disease
Pulmonary
* Forced expiratory volume (FEV)\_1 at least 1.0 L/sec
* No uncontrolled bronchospasms
* No uncompensated chronic obstructive pulmonary disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pre-existing peripheral neuropathy grade 2 or greater
* No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix
* No other concurrent serious medical illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
* No concurrent intensity-modulated radiotherapy
Surgery
* See Disease Characteristics
Other
* At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks
* Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period
* At least 14 days since prior Hypericum perforatum (St. John's wort)
* No concurrent EIACDs
* No concurrent amifostine during chemoradiotherapy
* Concurrent gabapentin or other non-EIACDs allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00059761
Study Brief:
Protocol Section:
NCT00059761